It is known that irrigation of the ear with a warm solution is beneficial to removing cerumen (ear wax) as well as foreign material from the ear canal. Both of these frequently occur in the outer ear canal passageway.
The presence of cerumen and other materials may block the normal passage of sound. The present invention is an improvement over prior techniques for irrigation of the ear canal. It contemplates the application to a patient's ear of a pulsating flow of warm water at a temperature of 100.degree. F., or slightly higher. The pressure of the water can be adjusted to pulsate between a pressure of 0 psi and 25 psi, to between 0 psi and 75 psi, at a frequency substantially above 100 cycles per minute--preferably in the order of 1,000 cycles per minute or more.
The solution is applied to the ear canal by means of an applicator having a tubular body, including an elongated tube portion at least several inches long. The proximal end attaches to a handpiece, having a passageway connected to a source of pulsating water solution by means of a male connector. A simple valve on the handpiece allows the operator to turn the water on and adjust the amount of water that goes to the ear irrigator tip.
The distal end of the tube and the end that is introduced into the ear are modified from a standard tubing in the following manner:
1. The end is sealed with a smooth, convex portion presenting towards the eardrum. In the event that the patient accidentally moves and strikes the end of the ear irrigator, the convex smooth end presents an area least likely to produce injury to the eardrum or the canal.
2. Three openings are made into the closed tubing. These openings exit from the sides of the tubing at an angle between 10.degree. and 30.degree. from the length of the tubing. Two openings are made on the left side of the tubing, and one operning is on the right side of the tubing. The diameter of these openings may vary, except that the sum of the two openings on the left side is equal to the diameter of the opening on the right side.
3. Above and external to these openings, grooves are cut which lead to the area of the holes. By having three lateral grooves, a three-part escape mechanism is provided in the event that the irrigator seals within the ear canal. By providing these three exit means, the force of the water pressure cannot be raised between the ear irrigator and the drum.
4. The end of the ear irrigator device is truncated. Therefore, in most situations, the ear canal will be much larger than the end which is introduced into the ear canal.
5. Three elevations are located near the proximal end. These correspond to the three openings to indicate their location when the openings are within the ear canal.
6. The ear irrigator attaches by a male connector to a pump irrigator, female counterpart. This connector allows for free rotation of the distal end.
7. A finger grip is provided for better holding and control of the tip.
8. The tip has several shapes:
A. Straight. PA0 B. Distal end angled at 30.degree.. PA0 C. Distal end angled 60.degree.. PA0 D. Other shapes to suit the physician's uses.
9. The longitudinal position of the three exit holes, from which the water ejects, may vary in relation to each other as in relation to the distal end. This is for the purpose of obtaining a greater degree of rocking of the cerumen, or a lesser degree of rocking of the cerumen--as is desired by the operator. When the holes are located at the same level, there is a slightly lesser degree of rocking; when the large hole is positioned below the level, or proximal to the level of the two smaller holes, a greater degree of rocking is achieved. This is because the water jets strike at different time elements, achieving greater rocking action. Various combinations will be available for varying uses.
Current means of ear irrigation include a large syringe with a large tip. This syringe is alternately filled with water and the syringe forces a stream at large pressure into the ear. No cerumen may be removed if the cerumen is water insoluble. The operator has little or no control over the force of the water being ejected; he cannot see the stream, and the tip often clogs the ear canal and raises pressure very high, and may at times rupture the eardrum.
Or, a pulsating stream my be directed straight forward against the cerumen and eardrum, pulsing at 1,200 pulses per minute. The force striking the eardrum could injure the eardrum, and might cause a rupture. The water pulsing at 1,000 pulses per minute, or greater, would cause the eardrum to vibrate at this rate, thereby causing unusual movement of the eardrum and the three ossicles--maleus, incus and stapes--attached thereby. This forceful movement of the stapes bone within the middle and inner ear is known to be potentially dangerous, and may cause damage to hearing. Because the stream jets forwardly, the distal end of the irrigator vibrates excessively causing abrasion and injury of the ear canal as the end piece moves about irregularly in a circular manner. In addition, the hand piece also vibrates and moves, making it difficult to direct the stream in a desired manner. The water striking straight forward, may strike directly backwards, striking the operator's eye.
Therefore, it is the purpose of this invention to provide a means of utilizing the advantages of pulsing jet stream with the safety of a stream directed in such a manner that it cannot strike the eardrum. In addition to the washing action of the water, the rocking action provides a means of removal of cerumen which is water insoluble. The pulsing action, in addition, helps to remove cerumen. The pulsation and movement of the distal end is reduced by the three jet-opening action. The angle of ejection is such that the water does not strike back in the operator's eye.
The danger of increasing water pressure excessively is prevented by this method because of the three escape grooves, and because the force of the pressure is controlled by means of the pulsating jet source. The source of pulsating flow of water, in accordance with the invention, is most conveniently provided by the conventional device presently being marketed for dental hygiene using a pulsating jet of water, or desired solutions for cleaning the teeth and invigorating the gums. A particular model is provided, such that when the tip is attached the handpiece provides a comfortable, convenient hand grip for the operator, with its own on/off switch to provide one-hand operation with maximum control.